BRUFEN Film Coated Tablet 400 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-03-2023
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Active ingredient:
IBUPROFEN
Available from:
Abbott Laboratories Ireland Ltd
Dosage:
400 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2004-10-19
Summary of Product characteristics
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Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Brufen 400mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Brufen Tablet contains 400 mg of Ibuprofen.
Excipients: each tablet contains 26.7mg of lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film – coated Tablet.
A white, pillow-shaped, film-coated tablet.
4 CLINICAL PARTICULARS
4.1 Therapeutic Indications
Brufen is indicated in the symptomatic management of various arthroses such as rheumatoid arthritis (including
juvenile rheumatoid arthritis or Still’s disease) and osteoarthritis, fibrositis, ankylosing spondylitis and other muscular
syndromes, such as low back pain, soft tissue trauma and various inflammations of tendon, joint capsules and
ligaments.
Brufen is also used as an analgesic in the relief of mild to moderate pain.
4.2 Posology and method of administration
For oral administration.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control
symptoms (see section 4.4, Special warnings and special precautions for use).
Adults: The recommended dosage of Brufen is 1200-1800 mg daily in divided doses. Some patients can be maint
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